■ iSTAR Medical announced that the first patients have been implanted in its STAR-VI international trial evaluating safety and efficacy of MINIject in conjunction with cataract surgery in patients with primary open-angle glaucoma. MINIject is a minimally invasive device that is currently the only commercially available supraciliary MIGS implant.
The STAR-VI trial is a prospective, interventional, multicenter, single-arm study aiming to implant a total of 30 patients at up to 7 sites in Europe and Central America. Patients will be followed for 2 years after their cataract surgery and concurrent MINIject implantation. The primary endpoint of the trial is the proportion of patients achieving a ≥20% reduction in diurnal IOP from baseline to 6-month follow-up, regardless of the use of IOP lowering medication.
“The initiation of our global STAR-VI trial is an important step in bringing MINIject to more patients around the world, including those with co-existing ocular conditions. We are committed to delivering our breakthrough eye care solutions to patients globally and look forward to reporting clinical data from this study in due course,” Michel Vanbrabant, CEO of iSTAR Medical, said in a news release.